Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte
First Claim
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1. A method of demonstrating increased accuracy of a test strip, the method comprising:
- providing a batch of test strips;
introducing a referential sample containing a referential concentration of an analyte to each test strip of the batch of test strips to initiate a test sequence;
reacting the analyte with a reagent on each test strip to cause a physical transformation of the analyte;
determining a physical characteristic of the referential sample;
deriving a defined batch slope for the batch of test strips based on the determined physical characteristics of the referential sample for selected test strips from the batch of test strips;
determining an approximate analyte concentration of the referential analyte concentration as being in one of a low glucose range, a medium glucose range or a high glucose range;
determining a sampling time point based on the approximate analyte concentration of the referential analyte concentration, the determined sampling time point being selected as a first sampling time point responsive to the approximate analyte concentration being in the low glucose range, a second sampling time point responsive to the approximate analyte concentration being in the medium glucose range, and a third sampling time point responsive to the approximate analyte concentration being in the high glucose range;
sampling an electrical output of the referential sample at the determined sampling time point during the test sequence;
calculating an analyte concentration based on the defined batch slope, the determined sampling time point and sampled electrical output to provide for a final analyte concentration value for each test strip of the batch of test strips such that at least 95% of the final analyte concentration values of the batch of test strips are within ±
15% of the referential analyte concentration.
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Abstract
Various embodiments for methods and systems that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic of the sample containing the analyte and deriving one of a batch slope, sampling time, or combinations thereof to attain accurate glucose concentration.
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Citations
15 Claims
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1. A method of demonstrating increased accuracy of a test strip, the method comprising:
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providing a batch of test strips; introducing a referential sample containing a referential concentration of an analyte to each test strip of the batch of test strips to initiate a test sequence; reacting the analyte with a reagent on each test strip to cause a physical transformation of the analyte; determining a physical characteristic of the referential sample; deriving a defined batch slope for the batch of test strips based on the determined physical characteristics of the referential sample for selected test strips from the batch of test strips; determining an approximate analyte concentration of the referential analyte concentration as being in one of a low glucose range, a medium glucose range or a high glucose range; determining a sampling time point based on the approximate analyte concentration of the referential analyte concentration, the determined sampling time point being selected as a first sampling time point responsive to the approximate analyte concentration being in the low glucose range, a second sampling time point responsive to the approximate analyte concentration being in the medium glucose range, and a third sampling time point responsive to the approximate analyte concentration being in the high glucose range; sampling an electrical output of the referential sample at the determined sampling time point during the test sequence; calculating an analyte concentration based on the defined batch slope, the determined sampling time point and sampled electrical output to provide for a final analyte concentration value for each test strip of the batch of test strips such that at least 95% of the final analyte concentration values of the batch of test strips are within ±
15% of the referential analyte concentration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification